Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

MedtronicNeuro17 enrolled

Overview

The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems. This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neurogenic Overactive Bladder Urinary Incontinence Detrusor Overactivity

Interventions

InterStim TherapyDEVICE

Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Incomplete upper motor neuron lesion * Detrusor overactivity * Two leaks or two notices of leaks per day * Mean functional bladder capacity (volume voided per episode) of ≥100 ml Exclusion Criteria: * Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves. * Degenerative disease of the central nervous system

Locations (8)

Universitair Ziekenhuis Gent

Ghent, Belgium

Centre Hospitalier Universitaire de Lyon-Sud

Lyon, France

Hôpital de la Pitié Salpétrière

Paris, France

Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum

Herne, Germany

Outcomes

Primary Outcomes

Functional Bladder Capacity

Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.

Time frame: Baseline, 4 weeks after implant, 8 weeks after implant

Data from ClinicalTrials.gov

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